As a director of POCT, a pathologist has not only the opportunity to provide broad oversight and direction, but to be directly involved with the entire spectrum of caregivers in selecting, guiding, and assessing POCT for a wide variety of traditional and nontraditional care environments.

The role of Laboratory Director confers legal, regulatory, technical, fiscal and ethical responsibilities on a pathologist. In the US, most of those responsibilities are assigned through the Center for Medicare and Medicaid Services (CMS) via CLIA88. Additional responsibilities or requirements may be defined by states, professional societies, or accrediting agencies, (e.g., the College of American Pathologists (CAP), the Joint Commission (TJC),) or other agencies such as local regulatory bodies. International sites have their own governing bodies but frequently also follow CDC, World Health Organization (WHO), and International Standards Organization (ISO) guidelines. Increasingly, organizations and agencies are looking to set international standards. Future editions of this Tool Kit will emphasize those.

The primary leadership roles defined by CLIA88 as noted above are: Laboratory Director, Clinical Consultant and Technical Consultant. Other CLIA88 defined roles are those of Technical Supervisor, General Supervisor and testing personnel. While pathologists may assume any these roles, generally the latter are delegated to technical personnel.

Under CLIA88 and state regulations, a Laboratory Director can be a physician or doctoral level scientist with appropriate training and experience. For any POCT that is non-waived, personnel who do not meet this requirement cannot serve as Laboratory Directors. Waived testing has no CLIA88 personnel standards nor Laboratory Director requirements, but some states do have higher standards. It is important to know your state or local requirements to be a Laboratory Director for any type of testing. Individual organizations may also set specific requirements to direct waived testing and it is essential to know those when overseeing a program. The following discussion also applies to non-pathologist physicians and doctoral level scientists as Laboratory Directors, but it focuses on the role of pathologist. Much of the remainder of this Tool Kit applies generally to anyLaboratory/medical Directorship roles of a pathologist, but with a focus on POCT.

The CLIA 88 regulations are organized into Subparts and Sections. Subpart M addresses personnel requirements for non waived testing, first defining the Laboratory Director. To summarize, the Laboratory Director is responsible for:

The overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures

The director may perform the roles of Clinical Consultant, Technical Consultant, and testing personnel but he/she may delegate them to qualified personnel. However, the director always remains responsible that all duties are properly performed. A Laboratory Director risks losing his/her ability to direct any laboratory for at least two years if all required duties are not properly carried out. More serious legal consequences may ensue if there is harm to patients or other personnel. Therefore, it is essential that the Laboratory Director maintains an active and effective role in running a laboratory. He/she cannot afford to be a casual or detached director. The director must show active and effective evidence of supervision and assurance of quality.

Since no director can perform all duties in a complex operation, he/she must have a good team. For POCT, the first and foremost member of that team is the POCT Coordinator or Supervisor. The responsibilities and support that person needs will be emphasized throughout this Tool Kit. A subsection written by an experienced POCT Coordinator further defines the duties and qualities of this person. Along with a strong relationship between the director and coordinator, no program can function effectively without also having strong partnerships with clinical and other healthcare colleagues.

CLIA88 also introduced the concept of the test complexity model, defining waived, moderately complex (including Provider Performed Microscopy or PPM) and highly complex testing. Much, but not all, of POCT is waived testing as previously discussed. Each complexity level has specific director requirements as outlined in Subpart M (CLIA88 Subpart M), but in general the requirements are similar, especially in hospital or more complex care environments. Even for the less stringent requirements of waived testing, recommendations for best practices exist. In 2005, CMS published findings of routine and focused surveys of waived testing sites and reiterated its recommendations for best laboratory practices. Some states, such as New York, do not recognize different complexity levels for any testing performed in accredited organizations such as hospitals or healthcare organizations. Some accrediting organizations, such as the CAP, require the same or similar standards for any testing performed. While this Tool Kit addresses the spectrum of POCT, the performance standards espoused are for best laboratory practices, regardless of test complexity, consistent with the recommendations and standards of the CAP.

General CLIA88 Laboratory Director responsibilities include being accessible onsite or by telephone or electronic consultations as needed and assuming the role of named director on no more than 5 CLIA certificates. In addition, the following essential director responsibilities are summarized:

Quality is assured in all aspects of testing.

There are adequate and safe physical plant and environmental conditions.

Test methodologies are capable of performing for patient care, their performance is verified, and testing personnel performs them as directed.

Proficiency testing is performed as required, results are reviewed and problems are addressed in corrective actions.

Effective quality control and assessment programs are in place.

All test systems have established and maintained levels of performance.

Remediation is taken when test performance deviates from standards and patient results are only reported when test systems are working properly

Reports have pertinent information for interpretation.

Consultation is available for questions on test quality and interpretation.

Sufficient numbers of properly educated, trained, and experienced personnel are employed to perform all required functions, including supervision and consultation

Before testing, all personnel must have training and competency assessed

There are policies and procedures for training, assessing, and remediating testing personnel

Procedure manuals are available for testing personnel.

The duties of each personnel member are specified in writing for all phases of testing.

Additional Laboratory Director responsibilities are defined by other organizations, including the CAP, the Joint Commission, the Commission on Laboratory Accreditation (COLA), and the American Association of Blood Banks (AABB) in the US. Given the comprehensive and detailed duties of Laboratory Director, it is obvious that any director needs education, training, experience, and support to fulfill his/her responsibilities. In this complex environment, having an experienced and dedicated team with adequate resources is fundamental. Again, a key member of the POCT team is the POCT Coordinator. We cannot over emphasize the importance of recruiting and partnering with a great POCT Coordinator as you develop your POCT team. The qualities and role of this critical person are addressed below in the words of an experienced POCT Coordinator.

The above summarizes many of the general requirements for any Laboratory Director. What makes POCT different from a central or traditional laboratory? Previously the unique aspects of POCT were discussed. To summarize:

POCT may be decentralized in numerous sites with different patient care goals and expectations.

Different sites will have different physical capacities and limitations.

Testing personnel are often not formally trained laboratorians; they have wide ranges of education, experience, motivation, and understanding of laboratory science.

Clinical needs and developments may be more rapidly changing (e.g. new practice sites, new specialty needs, public demand).

Public policy and regulatory drivers may be more varied and unpredictable.

So, given the complexity and uncertainties of POCT, why should a pathologist Laboratory Director get involved? A simple answer may be that your contractual relationship with your organization or practice group requires you to do it, but there really are more meaningful reasons to become a “POCT pathologist”. Why get involved in POCT?

As physicians and laboratorians, we are uniquely suited to evaluate, implement and interpret testing for patients on behalf of providers.

We have wide exposure to medical specialties and disease processes.

We are experienced in inpatient and outpatient settings.

We are communicators to many audiences.

We have training and experience in linking medical indications, technical options and performance, and financial implications.

We know how to manage varied personnel.

It is an opportunity to expand our practice horizons and move the laboratory out into direct patient care. POCT is a prime opportunity for pathologists to engage in the “transformation” of the specialty, moving from a background to a leading position in clinical care.

POCT is one of the high growth areas in laboratory testing; pathologists must be involved.

POCT can be frustrating but extremely gratifying in supplying an unmet need and promoting best practices for quality test results. No pathologist actively involved in POCT is ever bored!

POCT is an opportunity to perform value-added functions in an organization and work with a wider spectrum of peers.

POCT gives us the chance to respond more to what our colleagues want from us. The following are examples from a Nurse Director of Ambulatory Care services, and a practicing physician administrator on what they want and need from a laboratory director involved in POCT.

B. What an RN Ambulatory Care Administrator Would Like from a
Pathologist POCT Director:

A POCT Laboratory Director gives value to an administrator and organization by supporting the clinical team in providing timely and efficient patient care while remaining fiscally responsible to the institution. As numerous POC tests evolve, the administrator relies on the POCT Laboratory Director to make a well-rounded assessment of the impact of POC tests by developing sound business plans to ensure the institution does not invest in a technology that may not offer a significant benefit to patient care and may jeopardize the fiscal health of the institution. Ultimately, the administrator relies on the sound judgment of the POCT director to assess the true benefit of testing while diplomatically dealing with the possible unfounded laboratory demands of non-laboratorians.

Too often in the physician’s office decisions are made by practice managers or non-clinical staff who are wooed by sales representatives’ claims of quick and easy results from a POC test that will supposedly generate revenue for the practice. There may be no mention of CLIA certificates or moderate complexity testing requirements. It is a rare physician who inquires about validation studies to evaluate accuracy or comparability with standard methods or considers the impact of control testing, storage conditions, or other issues on results. Along with his/her own team members (such as a POCT Coordinator), the POCT Laboratory Director can tactfully educate peers and practices about these issues so that testing is safe and meets expectations. The director and coordinator then become valued ongoing resources to providers and other members of the team.

The POCT Laboratory Director ideally understands the financial implications of POCT to the practice and works to achieve realistic solutions. As a supportive peer, the POCT director can work with the practice to understand realistic expectations. The POCT Laboratory Director is then willing to explore the best means to meet the practice’s needs, using POCT or conventional testing to accomplish the task within the required turnaround time. The POCT director is also an important advocate and resource for regulatory compliance.

In summary, the POCT Laboratory Director is a valued colleague who works collaboratively with practitioners and administrators to achieve the highest possible standards of care, using appropriate technology and providing expert knowledge to accomplish the end goal of safe, appropriate, evidence-based patient care.

C. What an MD Administrator Wants from a POCT Pathologist

A POCT Laboratory Director gives value to an administrator and organization by supporting the clinical team in providing timely and efficient patient care while remaining fiscally responsible to the institution. As numerous POC tests evolve, the administrator relies on the POCT Laboratory Director to make a well-rounded assessment of the impact of POC tests by developing sound business plans to ensure the institution does not invest in a technology that may not offer a significant benefit to patient care and may jeopardize the fiscal health of the institution. Ultimately, the administrator relies on the sound judgment of the POCT director to assess the true benefit of testing while diplomatically dealing with the possible unfounded laboratory demands of non-laboratorians.

Administrator wants:

Oversight of all scientific, medical, technological and support functions in an effective and efficient manner including:

Ensuring the licensure, certification or registration of the involved staff

Provision and monitoring of related continuing educational activities of the medical staff, nurses and other clinical staff, and student or resident clinical education, if applicable

Effective communication and interaction with accrediting, regulatory, administrative groups, the medical community and the patient population served

Support for the continuum of care from the community to the health care institution by:

Participating in and, where appropriate, leading the development of local and regional service delivery models

Encouraging laboratory service delivery systems that optimize cooperation among service providers and minimize duplication

Leadership in development and implementation of patient focused laboratory services, including delivery systems that optimize services to achieve the desired health outcomes for patients

D. POCT Coordinator Development and Role

In order to support or lead an effective POCT program, a pathologist Laboratory Director needs to use all his/her skills as a leader, communicator, and educator. Essential to that function is recruiting, mentoring, and supporting a POCT Coordinator. Below, in the words of an experienced POCT Coordinator and educator, is a discussion of that role.

The role of a POCT Coordinator is a unique one. Many diverse skills are required for the POCT Coordinator to be successful in his/her role. Excellent laboratory technical competencies serve as the basis for the role. In selecting and mentoring a POCT Coordinator, the pathologist Laboratory Director should be aware of the variety of additional skills that will be required. The following are some characteristics to look for when selecting such an individual and provide a framework for mentoring emerging laboratory leaders for the challenging role of POCT Coordinator.

The individual should have a history of a strong patient-centered focus and good customer service experience and skills. Since the coordinator acts as a liaison between the central laboratory and the POCT site(s), the individual should be able to collaborate well with non-laboratory personnel to ensure effective testing operations and promote patient-focused care.

A candidate for POCT Coordinator should have exemplary written and oral communication skills. This individual may be called upon to draft policies and procedures, design training and competency modules, communicate with a variety of healthcare professionals regarding POCT regulatory compliance issues and give presentations to POCT personal. This individual should be comfortable in communicating with all levels of healthcare personnel including patient caregivers, administrators, medical directors and other senior leaders.

The POCT Coordinator should be able to work in partnership with the Laboratory Director, respecting the director’s responsibilities, keeping the director apprised of developments, but being independent enough to carry out routine functions and also advise the director. The director and coordinator should have a clear understanding of their roles and relationship. See below.

The POCT Coordinator should also be successful in working in and leading teams. Advanced training in process improvement/LEAN/Six Sigma can provide the individual with added tools in facilitating a quality POCT program.

The POCT Coordinator should exhibit creative problem solving and strong facilitation and negotiation skills. As a leader, this individual should be able to successfully “respect and leverage separate realities”, while working to establish a common vision and values related to POCT testing. The goal of these efforts is to produce quality POCT testing within the shared realities of laboratory and non-laboratory departments.

To support a POCT Coordinator in their role, the following characteristics of a Laboratory Director are desired:

Coach and mentor the POCT Coordinator in developing his/her skills for the role.

Provide support to the POCT Coordinator by communicating with facility medical/administrative directors when significant regulatory compliance issues are unable to be immediately resolved.

Interact with facility administrators and medical directors of other disciplines on a regular basis. Participate in and/or coordinate interdisciplinary committees related to POCT or other laboratory issues.

Understand the risks and benefits of POCT implementation in various settings. Be willing to see a POCT issue from all sides and understand it both clinically and administratively.

Keep abreast of new POCT technology and new application of current technology and promote discussions regarding such with POCT Coordinators.

Be available to meet on a scheduled and unscheduled basis with the POCT Coordinator, both to meet regulatory compliance with oversight and review, but also to offer support, suggestions, and solutions for problem solving. Being a POCT Coordinator is a demanding role, and active director support is essential.

E. Beginning a Point Of Care Testing Program

Assuming that we respond to the challenge and get involved in POCT, where do we begin? A first action might be to define your own and the laboratory’s relationship to a program.

Are you the default or official director of POCT?

Is there an existing structure to the POCT program? Is it working?

Is the laboratory merely asked to advise on introducing POCT? Do you or other laboratory staff decide on whether POCT is implemented or do sources outside of the laboratory make their own decisions?

Is the laboratory looked at as hostile or supportive of POCT?

Is there an orderly process for evaluating, implementing and assessing outcomes of POCT?

Who has administrative or regulatory responsibility for the program?

Who bears the costs of testing?

What does your organization expect of you?

The answers to those and other questions will determine your next steps, but a recommendation is that you either evaluate your existing formal program or create a structure for your program. Most successful POCT programs have a plan with policies and procedures. Some POCT programs and directors prefer a less structured approach, but at the least, there should be some definition and predictability to your process so it is not haphazard and POCT introduction can become a more rational and reliable process. However the pathologist Laboratory Director is involved in POCT, is he/she a valued and respected member of that process? The POCT Coordinator is an important position in any program, and should be an official member of a program.

Options to consider in establishing, evaluating, or modifying any POCT program and policy include:

Leadership structure: is it centralized or decentralized? Pathologist- or central laboratory-led versus nurse- or clinician-led?

Composition of the leadership or decision making group or stakeholders? Is there an organizational chart?

Should there be a formal POCT committee? Or does a less formalized process work well in your setting?

Will the same structure apply to all sites (i.e., inpatient, outpatient, offsite)?

What are indications for performing POCT? What are the organization’s goals in providing POCT (e.g., service, quality, patient disposition, turnaround times, patient or provider satisfaction, new service lines, cost containment)?

What are the contraindications for performing POCT?

Relative (e.g., staffing)

Absolute (e.g., complexity model, staffing requirements, costs)

What is the process for requesting a new POC test and evaluating POCT?

Is the process communicated and followed? Is it effective, efficient, or practical?

What is the regulatory organization of the POCT program?

Centralized- main lab CLIA certificate covers all POCT within the organization

Distributed: every site performing POCT has its own CLIA certificate

Combined: some sites are under the central lab and others have their own CLIA certificates

Due to the repercussions of a revoked CLIA certificate (director cannot direct any lab for 2 years, laboratory cannot bill Medicare/Medicaid) and the issues that may arise regarding maintaining regulatory compliance when the testing staff are not laboratorians, there may be distinct advantages to not covering POCT sites with the central laboratory CLIA certificate.

Does the certificate holder have actual responsibility for the program? Is there responsibility without authority?

Is the central laboratory a resource, partner, collaborator, or overseer of POCT? Is it intimately involved or dissociated from POCT?

Is there a cost benefit analysis projected before implementing POCT and is there a post implementation analysis?

What is revenue from POCT? Who bills? Who collects? Whose budget covers costs?

Is there an established quality management program? Are goals set, monitored, assessed, and reported?

Are quality effectiveness and/or outcomes measured?

Are there a safety, risk management, and compliance programs?

Are there educational and support resources provided or available (e.g., ListServs, peers, professional organizations, skills fairs)?

What are relationships with vendors and how are these managed? Is there a central process vendors must follow?

It is often advisable to have POCT vendors deal with the POCT oversight structure rather than dealing directly with clinicians and/or clinical sites so that the motivations and decisions to implement POCT are well grounded.

Is there accountability and reporting structure for the program? Is there an annual report? Who receives the report?

A Laboratory Director needs to be a good communicator and create a culture of communication if his/her efforts at guiding decision making and implementation are to be successful. POCT especially requires a multidisciplinary approach to reaching the wide stakeholder audience. This is another example where having an excellent coordinator and clinical partners is critical to effective communication and building understanding in the interest of high quality patient care.

First, the audience needs to be defined and for POCT the following groups need to be considered:

Other pathologists and laboratory professionals who need to offer advice and support a process, especially for specialty testing such as microbiology or coagulation tests.

Providers who request POC tests or will be involved in their use.

Nurses and clinical staff who request POC tests, perform testing, or who will supervise testing.

Administrators, executive committee and board members interested in the provision of services, patient or provider satisfaction, outcomes and costs.

REPETITION, REDUNDANCY, VARIETY. Essential for any effective communication. Keep the audience engaged at appropriate levels and keep communications varied and as failsafe as possible. Try to minimize operator fatigue to important messages

G. A BUSINESS PLAN TOOL FOR POCT

Included in this Tools Section are a series of model tools that a pathologist Laboratory Director can use to evaluate and implement a POCT request or process. A director and laboratory can create its own process but this is a structured approach to considering a request for implementing a POC test and the process needed to achieve that. Later in this Tool Kit, in the Technical Consultant section and under “Selection of Appropriate Methodologies”, there is an alternate tool for evaluating devices, kits, etc. The tool included here is a more administrative one, with administrative and outcome measures. Obviously, this specific tool can be used for many processes in the clinical laboratory. In further editions of this Tool Kit, there will be case studies illustrating the use of these tools.

The tools are only meant to be general guides and may not include every contingency. Each institution has unique characteristics and structures that require customization of these tools.